Process intensification

Higher efficiency in the manufacturing and quality control of pharmaceutical products

The intensification of manufacturing processes is one of the major issues for the pharmaceutical industry in the future. Relying on multidisciplinary and innovative approaches, the process intensification offers more compact equipements and leads to more efficient processes with a great increase of the chemical manufacturing

For several years, the pharmaceutical authorities are promoting a transition toward continuous manufacturing, an ICH Q13 guideline on the continuous manufacturing of drug substances and drug products being currently under redaction. The intensification of processes by the implementation of micro- or milli-structured reactors and the shifting from traditional batch manufacturing to continuous processes, offers more efficient and well controlled manufacturing processes.

Full characterisation of the process since lab scale

Among all its advantages, the possibilities of scale-up via replication of a unit system guarantee the consistency of the product over scale-up and therefore allow a full characterisation of the process since lab scale. It gives the opportunity to design an equipment dedicated for a defined product and specification, hence being in adequacy with the pharmaceutical authorities’ guidance for quality by design. Besides, a better monitoring and control over the critical process parameters and a well understood process will allow a model-based control affording an enhanced product quality consistency.

Lower reaction volumes:

  • Low risks
  • Low working capital
  • Small process footprint

Higher heat and mass transfer:

  • Uniform temperature
  • Plug flow – Narrow RTD
  • No mass transfer limitation
  • Broader range of (T, P, C) accessible
  • Efficient PAT integration

Better control of the process:

  • Higher stability
  • Lower risks
  • Better understanding

Model based control:

  • Quality by Design
  • Efficient control strategy
  • Real time release

Easier scale—up:

  • Reduced development cycles
  • Contained danger of sclae-up failure
  • Opportunities for low scale development
  • Reduced material consumption

Tailored support, every step of the way

SECOYA accompanies its clients throughout the development and implementation of their intensified chemical processes. We are there for every step of the process development, from the initial determination of thermokinetic descriptors, in order to build a comprehensive model for the manufacturing and validation of operational pilot units. These can then be replicated to achieve the targeted production capacity.